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This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.

Specific mineral & vitamin combined preparations

Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.

Syrup-

• Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
• Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
• Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.

Tablet-

• Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.

This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.

Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.

Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.

This is recommended in pregnancy and lactation.

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Vitamin-C Preparations

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

Oral administration-

• For the prevention of scurvy: 1 tablet daily
• For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
• For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
• In other cases: 1 tablet daily or as directed by the physician.
• Maximum safe dose is 2000 mg daily in divided doses.

Parenteral administration-

• Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
• For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
• The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
• To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

Should be stored in a dry place below 30˚C.

This combination is indicated in-

• Vaginal trichomoniasis
• Vaginal leucorrhoeas
• Mixed vaginal infections (Fungal or Bacterial).

Drugs used in Vaginal and Vulval condition

Metronidazole, a nitroimidazole, is active against various anerobic bacteria and protozoa. Nystatin is a polyene antibiotic with antifungal activity. Neomycin is an aminoglycoside. It is bactericidal and active against some gram-positive and gram-negative organisms. Polymyxin is active against gram-negative organisms including Pseudomonas aeruginosa.

One suppository in the vagina at bedtime for 12 days or as directed by the physician.

Skin rash, urticaria may occur rarely.

Contraindicated to the patients who are hypersensitive to Metronidazole, Neomycin Sulphate, Polymyxin B Sulphate and Nystatin.

Caution should be taken in case of renal impairment.

Caution should be practiced in pregnancy and lactation.

Store in a cool and dry place, away from light & children.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.

Iron & Vitamin Combined preparations

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently

It is recommended during pregnancy and lactation.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Store in a dry place below 25° C. Protect from light.

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt):

• Base priming,
• Reverse transcription of the negative strand from the pregenomic messenger RNA, and
• Synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.

The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Missed Dose: If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.

The most common adverse events are headache, fatigue, dizziness and nausea.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.

Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.

Co-administration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co-administration of Entecavir with other drugs that are eliminated through renal or are known to affect renal function have not been evaluated and patients should be monitored closely for adverse events when coadministered with such drugs.

There are no data on the effect of Entecavir on the transmission of HBV from mother to infant. Therefore, appropriate care should be taken. It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Entecavir.

Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established.

Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below:

• CrCl ≥50 ml/min: 0.5 mg every 24 hours
• CrCl 30 to <50 ml/min: 0.5 mg every 48 hours
• CrCl 10 to <30 ml/min: 0.5 mg every 72 hours
• CrCl <10 ml/min or  Hemodialysis or CAPD: 0.5 mg every 7 days

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Helps to protect cells against oxidative stress.

Supplements & adjuvant therapy

Hypersensitivity to the active substance or to any of the excipients.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Multi-vitamin & Multi-mineral combined preparations

This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.

One tablet daily or as recommended by the physician.

Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

Indicated for the quick relief from pain, swelling and inflammation due to musculo-skeletal disorders such as sprains, strains, tendinitis, bursitis, hands, neck & shoulder pain, sciatica, muscle stiffness, joint pain, back ache and lumbago.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Diclofenac Diethylamine is systemically absorbed through the skin; it inhibits the enzyme cyclooxygenase, thus reducing the formation of PGE2. Moreover, it also increases the uptake of Arachidonic acid into the cellullar pool. Menthol is a vasodilator. It dilates the blood vessels, produces a feeling of coolness and produces analgesia. Methyl salicylate is a known anti-inflammatory agent.

Approximately one-inch band of gel should be applied to the affected site three to four times daily with rubbing till the film disappears. Safety and effectiveness in pediatric patients have not been established.

Usually well tolerated. Extremely low frequency of hypersensitivity reactions.

Known hypersensitivity to any part of the preparation.

For external use only. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.

The safety of this gel has not been established during pregnancy. There are no well-controlled studies of diclofenac in pregnant women.

Store below 25°C. Protect from light. Do not freeze. Keep out of reach of children. Close cap tightly after each application.

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.

Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).

Herpes simplex & Varicella-zoster virus infections

Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.

Adult Dosage:

Cold Sores: 2 grams every 12 hours for 1 day

Genital Herpes:

• Initial episode: 1 gram twice daily for 10 days
• Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy
• Immunocompetent patients: 1 gram once daily
• Alternate dose in patients with < 9 recurrences/year: 500 mg once daily
• HIV-infected patients: 500 mg twice daily
• Reduction of transmission: 500 mg once daily

Herpes Zoster: 1 gram 3 times daily for 7 days

Pediatric Dosage:

• Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day
• Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).

Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.

Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients

No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.

Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.

Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.

Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.

Store in cool & dry place, away from children.

Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).

Herpes simplex & Varicella-zoster virus infections

Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.

Adult Dosage:

Cold Sores: 2 grams every 12 hours for 1 day

Genital Herpes:

• Initial episode: 1 gram twice daily for 10 days
• Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy
• Immunocompetent patients: 1 gram once daily
• Alternate dose in patients with < 9 recurrences/year: 500 mg once daily
• HIV-infected patients: 500 mg twice daily
• Reduction of transmission: 500 mg once daily

Herpes Zoster: 1 gram 3 times daily for 7 days

Pediatric Dosage:

• Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day
• Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).

Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.

Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients

No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.

Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.

Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.

Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.

Store in cool & dry place, away from children.

Valganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated for the prevention of CMV disease in adult and pediatric solid organ transplant (SOT) patients who are at risk.

Anti-viral drugs

Valganciclovir is an L-valyl ester (prodrug) of ganciclovir, which after oral administration is rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2’-deoxyguanosine, which inhibits replication of herpes viruses in vitro and in vivo. Sensitive human viruses include human cytomegalovirus (HCMV), herpes simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus 6, 7 and 8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV) and hepatitis B virus.

In CMV-infected cells ganciclovir is initially phosphorylated to ganciclovir mono-phosphate by the viral protein kinase, UL97. Further phosphorylation occurs by cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolized intracellularly. This has been shown to occur in HSV- and HCMV-infected cells with half-lives of 18 and between 6 and 24 hours respectively after removal of extracellular ganciclovir. As phosphorylation is largely dependent on the viral kinase, the phosphorylation of ganciclovir occurs preferentially in virus-infected cells.

The virustatic activity of ganciclovir is due to inhibition of viral DNA synthesis by: (a) competitive inhibition of incorporation of deoxyguanosine-triphosphate into DNA by viral DNA polymerase and (b) incorporation of ganciclovir triphosphate into viral DNA causing termination of, or very limited further viral DNA elongation. Typical antiviral IC 50 against CMV in vitro is in the range 0.08 μM (0.02 μg/ml) to 14 μM (3.5 μg/ml).

The clinical antiviral effect of Valganciclovir has been demonstrated in the treatment of AIDS patients with newly diagnosed CMV retinitis (clinical trial WV15376). CMV shedding was decreased from 46% (32/69) of patients at study entry to 7% (4/55) of patients following 4 weeks of Valganciclovir treatment.

Standard Dosage: Valganciclovir is administered orally, and should be taken with food. Valganciclovir is rapidly and extensively converted into the active ingredient ganciclovir. The bioavailability of ganciclovir from Valganciclovir is up to 10-fold higher than from oral ganciclovir.

The dosage and administration of Valganciclovir tablets or powder for oral solution as described below should be closely followed. The ganciclovir systemic exposure following administration of 900 mg Valganciclovir powder for oral solution is equivalent to a 900 mg Valganciclovir dose administered as two 450 mg tablets.

An oral dosing dispenser with 25 mg graduations up to 500 mg is provided with the powder for oral solution. It is recommended that this dispenser is used to measure and administer the dose.

Treatment of cytomegalovirus (CMV) retinitis-

Adult patients:

• Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity
• Maintenance treatment of CMV retinitis: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dose is 900 mg once daily. Patients whose retinitis worsens may repeat induction treatment. The duration of maintenance treatment should be determined on an individual basis.

Pediatric patients: The safety and efficacy of Valganciclovir in the treatment of CMV retinitis have not been established in adequate and well-controlled clinical studies in pediatric patients. 

Prevention of CMV disease in transplantation-

Adult patients: For kidney transplant patients, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 200 days post-transplantation. For patients who have received a solid organ transplant other than kidney, the recommended dose is 900 mg once daily starting within 10 days post-transplantation and continuing until 100 days post-transplantation.

Pediatric patients: In pediatric solid organ transplant patients from birth, who are at risk of developing CMV disease, the recommended once daily dose of Valganciclovir is based on body surface area (BSA) and creatinine clearance (ClCr) derived from Schwartz formula (ClCr), and is calculated using the equation below:

Pediatric dose (mg)= 7 x BSA x ClCr. If the creatinine clearance exceeds 150 ml/min/1.73 m², then a maximum value of 150 ml/min/1.73 m²

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Hematologic Toxicity 
• Acute Renal Failure
• Impairment of Fertility
• Fetal Toxicity 
• Mutagenesis and Carcinogenesis

Valganciclovir is contraindicated in patients with known hypersensitivity to valganciclovir, ganciclovir or to any of the excipients.

In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for Valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of Valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug.

Pregnancy: The safety of Valganciclovir for use in pregnant women has not been established. However, ganciclovir readily diffuses across the human placenta. The use of Valganciclovir should be avoided in pregnant women unless the benefit to the mother outweighs the potential risk to the fetus. Reprotoxicity studies have not been repeated with valganciclovir because of the rapid and extensive conversion to ganciclovir. In animal studies ganciclovir was associated with reproductive toxicity and teratogenicity (see section 3.3.4 Reproductive Toxicity). The safe use of Valganciclovir during labor and delivery has not been established.

Lactation: Peri- and postnatal development has not been studied with valganciclovir or with ganciclovir but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the nursing infant cannot be discounted. Human data are not available but animal data indicates that ganciclovir is excreted in the milk of lactating rats. Therefore, a decision should be made to discontinue the drug or discontinue nursing taking into consideration the potential benefit of Valganciclovir to the nursing mother.

Pediatric Use: A higher risk of hematological cytopenias in neonates and infants warrants careful monitoring of blood counts in these age groups. Monitoring of liver function abnormalities, renal function and gastrointestinal fluid loss is also recommended in pediatric patients.

Geriatric Use: Safety and efficacy have not been established in this patient population

Renal Impairment: In patients with impaired renal function, dosage adjustments based on creatinine clearance are required.

Hepatic Impairment: Safety and efficacy have not been established in this patient population

Store Valganciclovir tablets at 20°C to 25°C; excursions are permitted to 15°C to 30°C

Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.

Combined antihypertensive preparations

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.

Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.

Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.

This combination product is contraindicated in patients who are hypersensitive to any components of this product.

Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.

No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.

Pregnancy Category D. It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in paediatric patients have not been established.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.

Combined antihypertensive preparations

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.

Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.

Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.

This combination product is contraindicated in patients who are hypersensitive to any components of this product.

Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.

No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.

Pregnancy Category D. It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in paediatric patients have not been established.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Valerian Root is indicated in-

• Insomnia
• Anxiety
• Nervous excitation
• Muscle spasm and pain
• Restlessness
• Migraine
• Lack of concentration

Herbal and Nutraceuticals

Valerian capsule is a special preparation of standardized extract of Valerian root. Valerian is a perennial herb, ranging from 2-5 feet in height, native to Eurasia and North America. Valerian acts as centrally depressive, sedative, tranquilizer, anxiolytic, antioxidant, spasmolytic, analgesic, anti-inflammatory and muscle relaxant.

1-2 capsule(s) daily 30 minutes before bed time or as prescribed by the physician.

No significant side effect has been observed in therapeutic dosage. Over dosage may cause headache, depression, nausea, lethargy, uneasiness, bradycardia, arrhythmias and decrease intestinal motility.

Valerian is contraindicated in case of hypersensitivity to the plant.

Valerian should not be administered during pregnancy, lactating mother and children without medical supervision.

Store in a cool and dry place. Protect from sunlight. Keep out of reach of children.

Vardenafil is used to treat erectile dysfunction (ED).

Drugs for Erectile Dysfunction

Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.

Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.

Renal impaired patients: In patients with renal impairment, no dose adjustment is required.

Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.

The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.

Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.

Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body

Vardenafil is not indicated for women.

The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.

Store at room temperature and protect from light and moisture. Keep out of the reach of children.

Vardenafil is used to treat erectile dysfunction (ED).

Drugs for Erectile Dysfunction

Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released in the corpus cavernosum & activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in an erection. Inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

The recommended starting dose: 10 mg once daily, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Vardenafil can be taken with or without food.

Geriatrics: A starting dose of 5 mg should be considered in patients >65 years of age.

Renal impaired patients: In patients with renal impairment, no dose adjustment is required.

Hepatic impaired patients: In patients with moderate hepatic impairment, a starting dose of 5 mg is recommended and the maximum dose should not exceed 10 mg. Do not use in patients with severe hepatic impairment.

The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.

Administration of Vardenafil with nitrates (either regularly or intermittently) and nitric oxide donors is contraindicated because Vardenafil may potentiate hypotensive effect of nitrates. It is also contraindicated for patients who have shown hypersensitivity to Vardenafil or any of the ingredients of this product.

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, Vardenafil generally should not be used.

Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body

Vardenafil is not indicated for women.

The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.

Store at room temperature and protect from light and moisture. Keep out of the reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Do not store above 30°C. Keep away from light and out of the reach of children.